The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bio-interference Screw, 7 Mm, 8 Mm, 9 Mm.
| Device ID | K971358 |
| 510k Number | K971358 |
| Device Name: | BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ARTHREX, INC. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-11 |
| Decision Date | 1997-07-09 |
| Summary: | summary |